Delivery systems and methods for transcatheter prosthetic valves

• US 9,675,454 B2
• Filed: 08/14/2012
• Issued: 06/13/2017
• Est. Priority Date: 07/30/2012
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Inventors: Schankereli, Kemal, Vidlund, Robert
• Primary Examiner(s): Scherbel, Todd J
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US14/418,130
• Publication Number:
  US 20150196393A1
• Time in Patent Office: 1,764 Days
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body

Abstract

This invention relates to a delivery apparatus and method for deployment of a mitral valve replacement.

Claims

1. A method of delivering to the mitral valve annulus of a heart a prosthetic mitral valve having a valve body expandable from a collapsed, delivery configuration to an expanded, deployed configuration, and having at least one anchoring tether including a ventricle portion extending from a ventricular end of the valve body and including an atrial portion extending from an opposite, atrial end of the valve body, and having an atrial cuff extending from the atrial end of the valve body, the method comprising:

delivering the valve to the left side of the heart through the atrial septum;

anchoring the ventricle portion of the anchoring tether to a wall of the ventricle of the heart;

causing the valve body to move from the delivery configuration to the deployed configuration, with the valve body disposed in the mitral valve annulus and with the atrial cuff engaging the atrial side of the mitral valve annulus;

pulling on the atrial portion of the anchoring tether to tighten the ventricle portion of the tether and urge the atrial cuff against the native valve annulus; and

fastening the anchoring tether to the valve body to fix the length of the ventricle portion of the anchoring tether.

2. The method of claim 1, wherein the anchoring the ventricle portion of the anchoring tether includes attaching the ventricle portion of the anchoring tether to a wall of the ventricle of the heart with a tether anchor device coupled to the wall of the ventricle.

3. The method of claim 1, wherein the anchoring the ventricle portion of the anchoring tether includes attaching the ventricle portion of the anchoring tether to a wall of the ventricle of the heart with an anchor device that includes a first portion coupled to a first side of the wall of the ventricle and a second portion coupled to an opposite side of the wall of the ventricle.

4. The method of claim 1, wherein the anchoring the ventricle portion of the anchoring tether includes attaching the ventricle portion of the anchoring tether to the septal wall of the ventricle of the heart.

5. The method of claim 1, wherein the anchoring the ventricle portion of the anchoring tether includes attaching the ventricle portion of the anchoring tether to the septal wall of the ventricle of the heart with a tether anchor device.

6. The method of claim 1, wherein the causing the valve body to expand includes removing a delivery sheath from the valve body.

7. The method of claim 1, further comprising:

prior to the anchoring the ventricle portion of the anchoring tether, inserting a delivery device through the mitral annulus, through the left ventricle and piercing the septal wall of the ventricle, the delivery device including a delivery sheath defining a lumen and the prosthetic mitral valve being disposed within the lumen of the delivery sheath during the inserting the delivery device.

8. The method of claim 1, wherein the prosthetic mitral valve further includes a plurality of tensioning tethers coupled to the valve body and extending from a delivery sheath, the method further comprising:

after the fastening the anchoring tether to the valve body, clipping the plurality of tensioning tethers from the delivery sheath; and

knotting the plurality of tensioning tethers to the prosthetic heart valve.

9. A method of delivering to the mitral valve annulus of a heart a prosthetic mitral valve including a valve body and having a collapsed, delivery configuration and an expanded, deployed configuration, and at least one anchoring tether extending from the stent body, the method comprising:

inserting a delivering device into the left side of the heart through the atrial septum, the delivery device including a delivery sheath defining a lumen and the prosthetic mitral valve being disposed within the lumen in the collapsed, delivery configuration;

inserting the delivery device through the mitral annulus, through the left ventricle and piercing the septal wall of the ventricle,

anchoring a portion of the anchoring tether to the septal wall of the ventricle of the heart;

moving the delivery device back through the mitral annulus and within the atrium such that the valve body is moved to the expanded, deployed configuration, and is disposed in the mitral valve annulus;

pulling on the anchoring tether to tighten the anchoring tether and urge at least a portion of the valve body against the mitral valve annulus; and

fastening the anchoring tether to the valve body to fix the length of the anchoring tether between the valve body and the septal wall of ventricle.

10. The method of claim 9, wherein the anchoring the portion of the anchoring tether includes attaching the portion of the anchoring tether to the septal wall of the ventricle with a tether anchor device.

11. The method of claim 9, wherein the anchoring the portion of the anchoring tether includes attaching the portion of the anchoring tether to the septal wall of the ventricle with an anchor device that includes a first portion coupled to a first side of the septal wall of the ventricle and a second portion coupled to an opposite side of the septal wall of the ventricle.

12. The method of claim 9, wherein the prosthetic mitral valve further includes a plurality of tensioning tethers coupled to the valve body and extending from the delivery sheath, the method further comprising:

after the fastening the anchoring tether to the valve body, clipping the plurality of tensioning tethers from the delivery sheath; and

knotting the plurality of tensioning tethers to the prosthetic heart valve.

13. A method of delivering to the mitral valve annulus of a heart a prosthetic mitral valve including a valve body and having a collapsed, delivery configuration and an expanded, deployed configuration, and at least one anchoring tether extending from the stent body, the method comprising:

accessing the left ventricle of the heart with a delivering device, the delivery device including a delivery sheath defining a lumen and the prosthetic mitral valve being disposed within the lumen in the collapsed, delivery configuration;

anchoring a portion of the anchoring tether to a first side of the septal wall of the ventricle of the heart with a first tether anchor device;

anchoring a portion of the anchoring tether to a second opposite side of the septal wall of the ventricle of the heart with a second tether anchor device;

deploying the valve body within the atrium of the heart such that the valve body is moved to the expanded, deployed configuration, and is disposed in the mitral valve annulus;

pulling on the atrial portion of the anchoring tether to tighten the anchoring tether and urge at least a portion of the valve body against the mitral valve annulus; and

fastening the anchoring tether to the valve body to fix the length of the anchoring tether between the valve body and the septal wall of ventricle.

14. The method of claim 13, wherein the prosthetic mitral valve further includes a plurality of tensioning tethers coupled to the valve body and extending from the delivery sheath, the method further comprising:

after the fastening the anchoring tether to the valve body, clipping the plurality of tensioning tethers from the delivery sheath; and

knotting the plurality of tensioning tethers to the prosthetic heart valve.

15. The method of claim 13, wherein the deploying the valve body includes removing a delivery sheath from the valve body.

16. The method of claim 13, further comprising:

prior to the anchoring the anchoring tether, inserting a delivery device through the mitral annulus, through the left ventricle and piercing the septal wall of the ventricle, the delivery device including a delivery sheath defining a lumen and the prosthetic mitral valve being disposed within the lumen of the delivery sheath during the inserting the delivery device.